Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT00862628
Status:
UNKNOWN
Last Update Posted:
2009-09-21
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C052785', 'term': 'rebamipide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of mucosal breaks', 'timeFrame': '4 and 8 weeks after treatment'}]}, 'conditionsModule': {'conditions': ['NSAIDs-induced Small-intestinal Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* 20 to 85 years of age\n* RA, OA, or low back pain\n* No change of drugs before 3 months\n* Under 5 mg of corticosteroid use\n* CRP \\< 1mg/dl\n* Small-intestinal mucosal injuries more than one\n* Hemoglobin level is below normal range\n\nExclusion Criteria:\n\n* Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis\n* Prostaglandins, metronidazole or salazosulfapyridine\n* Can not swallow\n* Eith pacemaker\n* After gastrointestinal operation\n* Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.\n* Taking rebamipide before one week\n* Any other conditions that the investigator feels would interfere with data interpretation or create under risk."}, 'identificationModule': {'nctId': 'NCT00862628', 'briefTitle': 'The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Nagoya University'}, 'orgStudyIdInfo': {'id': 'NO-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebamipide', 'interventionNames': ['Drug: Rebamipide']}], 'interventions': [{'name': 'Rebamipide', 'type': 'DRUG', 'description': '100mg tid, 4 or 8 weeks', 'armGroupLabels': ['Rebamipide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8550', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'contacts': [{'name': 'Naoki Ohmiya, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'nohmiya@med.nagoya-u.ac.jp', 'phone': '81-52-744-2172'}, {'name': 'Naoki Ohmia, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gastroenterology, Nagoya University Graduate School of Medicine', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-8550', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'contacts': [{'name': 'Naoki Ohmiya, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'nohmiya@med.nagoya-u.ac.jp', 'phone': '81-52-744-2172'}], 'facility': 'Department of Gastroenterology, Nagoya University Graduate School of Medicine', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}], 'centralContacts': [{'name': 'Naoki Ohmiya, MD., Ph.D.', 'role': 'CONTACT', 'email': 'nohmiya@med.nagoya-u.ac.jp', 'phone': '81-52-744-2172'}], 'overallOfficials': [{'name': 'Naoki Ohmiya, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nagoya University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagoya University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Gastroenterology', 'oldOrganization': 'Nagoya University Graduate School of Medicine'}}}}